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SRPT plans FDA filings to convert Amondys 45 and Vyondys 53 to full approvals, leveraging new data despite a missed endpoint in its confirmatory study.
The stock's decline comes as the company plans to submit supplemental new drug applications to the U.S. Food and Drug Administration (FDA) by the end of April, as detailed in the regulatory update.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided an update on its ongoing regulatory interactions with the U.S. Food and Drug Administration (FDA) regarding AMONDYS 45® (casimersen) and VYONDYS 53® (golodirsen) for the treatment of Duchenne muscular dystrophy (DMD). Sarepta requested a meeting with FDA to discuss submitting supplemental new drug applications (sNDA) seeking conversion of the ac.
Sarepta gains as enrollment begins in a new ENDEAVOR study cohort testing a sirolimus regimen to improve Elevidys safety in DMD patients.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced screening and enrollment are underway in Cohort 8 of ENDEAVOR (Study 9001-103). The purpose of Cohort 8 is to assess prophylactic sirolimus treatment as part of an enhanced safety protocol during treatment with ELEVIDYS (delandistrogene moxeparvovec-rokl) in non-ambulant individuals with Duchenne muscular dystrophy. Data from Cohort 8 will be u.
Sarepta Therapeutics, Inc. (SRPT) Presents at TD Cowen 46th Annual Health Care Conference Transcript
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the official opening of Route 79, The Duchenne Scholarship Program for the 2026-2027 academic year. Academic scholarships of up to $5,000 will be awarded to as many as 20 individuals living with Duchenne muscular dystrophy and five siblings of individuals living with Duchenne. “Since this program began nine years ago, significant progress has b.
AXQ Capital LP decreased its position in Sarepta Therapeutics, Inc. (NASDAQ: SRPT) by 72.8% in the undefined quarter, according to the company in its most recent Form 13F filing with the Securities and Exchange Commission. The firm owned 14,619 shares of the biotechnology company's stock after selling 39,088 shares during the quarter. AXQ
SRPT posts a wider Q4 loss as Elevidys sales tumble, but revenues top estimates and 2026 guidance outlines a cautious recovery path.
Although the revenue and EPS for Sarepta Therapeutics (SRPT) give a sense of how its business performed in the quarter ended December 2025, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will present at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, taking place March 8 - 11, 2026, in Orlando, Florida. At MDA 2026, Sarepta will present new and ongoing evidence across its rare neuromuscular portfolio, including commercially available gene therapy and exon-skipping treatments in Duchenne muscular dystrophy. Presen.
On Wednesday, Sarepta Therapeutics reported an adjusted loss of $3.58 per share, missing the Wall Street estimate loss of $1.31. Sales reached $442.93 million, beating the consensus of $391.92 million.
Sarepta Therapeutics CEO Douglas Ingram has decided to step down by the end of 2026 or upon the appointment of his replacement, the company said in a regulatory filing.
Sarepta Therapeutics, Inc. (SRPT) Q4 2025 Earnings Call Transcript
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2025. “Following a tumultuous 2025, we entered 2026 from a position of strength, founded on: (a) solid financial footing with a robust and growing cash balance, substantial revenue, and no near-term debt overhang, (b) durable approved therapies that are bringing a better life to patients, wi.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced the commercial launch of ELEVIDYS (delandistrogene moxeparvovec) in Japan by Chugai Pharmaceutical Co., Ltd., following its reimbursement listing on Japan's National Health Insurance (NHI) price list. Elevidys is the first gene therapy to be launched in Japan for Duchenne muscular dystrophy (DMD). In Japan, ELEVIDYS is available for ambulatory indivi.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will participate in a fireside chat at the TD Cowen 46th Annual Health Care Conference at the Boston Marriott Copley Place in Boston, Mass. on Tuesday, March 3 at 1:50 p.m. E.T. The presentations will be webcast live under the investor relations section of Sarepta's website at https://investorrelations.sarepta.com/events-.
Insights from the Fourth Quarter 2025 13F Filing Joel Greenblatt (Trades, Portfolio) recently submitted the 13F filing for the fourth quarter of 2025, providin
Sarepta Therapeutics (SRPT) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Public Sector Pension Investment Board acquired a new stake in shares of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) in the undefined quarter, according to the company in its most recent Form 13F filing with the SEC. The institutional investor acquired 381,172 shares of the biotechnology company's stock, valued at approximately $7,345,000. Public Sector Pension